Purification Processes

The staff at BioTechLogic has expertise in the purification of PEGylated and non-PEGylated proteins, antibody fragments, oligonucleotides and blood products. We have developed work processes, provided on-site manufacturing support and designed process steps using the following purification technology expertise:

  • Laboratory and industrial-scale liquid chromatography
  • High-pressure liquid chromatography
  • Ultrafiltration/Diafiltration
  • Rotary evaporation
  • Sterile filtration

BioTechLogic has experience in the design of unit operations. We provide knowledge and experience using various equipment and operating procedures, and consider validation requirements in the decision-making process.

 BioTechLogic accomplishments include:

  • Multiple biopharmaceutical IND filings (cytokines, proteins, antibody fragments) at 10 L to 10,000 L scale
  • Pre-Qualification activities for an antibody fragment produced at 10,000 L scale
  • RNA oligonucleotide synthesis process performed on solid support system validated and FDA approved for the first synthetically produced oligonucleotide
  • NDA approval and MAA positive opinion of a Growth Hormone Receptor Antagonist